August 2, 2021 – Federal Register Recent Federal Regulation Documents

We, NMFS, issue a final rule to revise the critical habitat designation for the Southern Resident killer whale (Orcinus orca) distinct population segment (DPS) under the Endangered Species Act (ESA) by designating six additional coastal critical habitat areas along the U.S. West Coast. Specific newly designated areas along the U.S. West Coast include 15,910 square miles (mi\2\) (41,207 square kilometers (km\2\)) of marine waters between the 20-feet (ft) (6.1- meter (m)) depth contour and the 656.2-ft (200-m) depth contour from the U.S. international border with Canada south to Point Sur, California. We have excluded one area, the Quinault Range Site (including a 10-km buffer around a portion of the site), comprising 1,400.4 mi\2\ (3627 km\2\), from the critical habitat designation because we have determined that the benefits of exclusion outweigh the benefits of inclusion, and exclusion will not result in extinction of the species.

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its medical product ``intended use'' regulations. This final rule amends FDA's regulations describing the types of evidence relevant to determining whether a product is intended for use as a drug or device under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Public Health Service Act (PHS Act), and FDA's implementing regulations, including whether a medical product that is approved, cleared, granted marketing authorization, or exempted from premarket notification is intended for a new use. This action also withdraws and replaces the portions of a final rule issued on January 9, 2017, that never became effective.